The following data is part of a premarket notification filed by Lily Imaging Solutions Co. with the FDA for Lily Dark Viewer.
Device ID | K954998 |
510k Number | K954998 |
Device Name: | LILY DARK VIEWER |
Classification | Illuminator, Radiographic-film |
Applicant | LILY IMAGING SOLUTIONS CO. 1966 LOOP RD. Fortuna, CA 95540 |
Contact | Gary H Baker |
Correspondent | Gary H Baker LILY IMAGING SOLUTIONS CO. 1966 LOOP RD. Fortuna, CA 95540 |
Product Code | IXC |
CFR Regulation Number | 892.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-01 |
Decision Date | 1996-01-29 |